PharmaSchool: Conducting IND Studies in Europe

Please contact Jo Burmester at jo.burmester@pharmaschool.co.uk to find out more about in-house courses and discuss your specific needs.

Course Code: GGL009

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Duration: 1 day

Description:

This course covers the key aspects of IND requirements which are relevant for an IND study in European sites.

Who it is suitable for:

Those involved in conducting clinical trials in Europe under FDA regulations, for example, Project Managers, CRAs, CTAs, investigators, study nurses.

Example content:

Overview of FDA and it's departments

Overview of Code of Federal Regulations Title 21

Relevant regulations for Clinical Research
FDA Guidelines relating to Clinical Research

When and how CFR applies in Europe

Key differences between US and EU requirements

FDA forms
FDA Inspections

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